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90% of pharmaceutical companies in Guizhou have traced vaccines

Release date: 2020-01-06 Views: 0

Source: Cypress Blue  

Already, more than 90% of pharmaceutical manufacturers have assigned codes and established a drug traceability system. The remaining unimplemented pharmaceutical companies need to hurry up.

▍This province has achieved full traceability of vaccines

Recently, Cypress Blue learned in the "Vaccine Factory Full Process Traceability Tour" held by the Guizhou Provincial Center for Disease Control and Prevention. At present, the digital vaccine monitoring system project implemented in Guizhou Province has realized the electronic traceability of vaccines and the temperature of vaccines throughout the jurisdiction. Automatic monitoring alarm.

The entire electronic traceability of vaccines in Guizhou Province enables every vaccine that flows into Guizhou Province, from the manufacturer to the CDC, CDC to the inoculation unit, to record and save the vaccine traceability data in a timely and accurate manner, so that the smallest packaging unit of the vaccine is in circulation and Use the whole process to trace the source and trace it.

It is understood that the digital vaccine surveillance system covers Guizhou Provincial Disease Control Center, 9 cities and prefectures, 88 county (urban) disease control centers, and 1579 vaccination units.

Since December 1, the "Vaccine Management Law of the People's Republic of China" has been formally implemented, and strict main responsibilities have been set for the whole process of the vaccine. Every vaccination must be traceable.

Paragraph 3 of Article 10 of the "Vaccine Management Law" stipulates that holders of marketing authorization for vaccines shall establish an electronic vaccine traceability system and connect with the national vaccine electronic traceability system collaborative platform to realize the smallest packaging unit of vaccine in the entire process of production, distribution and vaccination. Traceable and verifiable.

According to requirements, cities across the country must establish a comprehensive vaccine information traceability system before March 31 this year. With the implementation of the "Vaccine Management Law", the national vaccine electronic traceability coordination platform is about to enter the agenda, and now Guizhou has come to the forefront.

It should be noted that the higher-level law, the Drug Administration Law, which came into effect on the same day as the Vaccine Management Law, also requires drug market license holders, drug manufacturers, drug dealers, and medical institutions to establish and implement a drug traceability system in accordance with regulations. Provide traceability information to ensure drug traceability.

To a certain extent, the vaccine digital surveillance system project implemented in Guizhou Province has certain reference significance for medical institutions in other provinces and cities, vaccine enterprises, and even extended drug production enterprises.

▍How to solve the smallest traceback unit?

The problems and experience in the establishment of the vaccine traceability system will also inspire and guide the construction of the drug traceability system in the future.

During the visit, Cypress Blue saw that each scanning station was equipped with a code scanning gun. Before the vaccination, the nurse would scan the vaccine traceability code on the vaccine package in front of the children and parents. Only after the problem was vaccinated. In the past, the vaccination nurses recorded the basic information of the vaccine by handwriting or computer input. Scanning the code also reduced their workload and improved accuracy.

At present, the smallest traceable unit of vaccine is a box. Some vaccines have only one box, and some vaccines have five boxes. Five people are packed and packed into five people. How can I achieve traceability?

Ye Xingui, deputy director of the Guizhou Provincial Center for Disease Control and Immunization Planning, told Cypress Blue: This problem has really troubled them for a long time, such as Baibai broken, a box of five people packaging, now the system is limited, only scan code 5 is allowed Second, the fifth person can take the pill box. Therefore, they are now calling on vaccine manufacturers to improve multi-person vaccine packaging, preferably one box per person, to facilitate accurate traceability of the vaccination unit.

The same problem also occurs on the drug side.

A hospital has an inpatient department and an outpatient department. For the medicines that have been coded, because the smallest traceable unit of medicine is a box, the medicine issued by the outpatient department can still be traced to an individual; then a box of medicines in the inpatient department may be disassembled. How to trace back to different patients?

In this regard, the person in charge of Ali Health's drug traceability code business explained to Cypress Blue: The hospital can use the zero registration to achieve patient traceability.

A box of medicines corresponding to a code should be removed before being distributed to patients, and the registration should be zero-removed-for example, the medicines corresponding to this tracking code are packed in ten pieces, then it can scan the tracking code, and the system will then print out according to the packaging specifications 10 self-adhesive tickets, the format is "traceable code + number", retrospective codes 01, 02, 03 ... 10, each code has a number, put these 10 small tickets on different turnover bags Associated with the patient. In the overall traceability system, the number of scans can be limited according to packaging specifications and formulation specifications.

For doctors and nurses at medical institutions, does this make their work more complicated?

The person in charge further stated that in order to achieve internal fine-grained management, the hospital itself can accurately identify medicines by scanning codes, avoid errors caused by manual registration, and ensure the safety of patients' medications. Relatively speaking, it will make the work of doctors and nurses more convenient.

▍90% of pharmaceutical companies have been coded

CyberLink has learned that through three years of market-oriented operations, more than 90% of pharmaceutical manufacturers and 100% of vaccine manufacturers have settled in Ali Health's "Reliable on the Code" traceability platform.

According to the new Drug Administration Law, the State Drug Administration has issued several drafts of consultations on the construction of drug traceability systems. Shandong, Gansu, Hainan, Heilongjiang and other provinces have issued notices on the construction of drug traceability systems.

The urgency of the policy has led many pharmaceutical companies to choose to cooperate with third-party platforms. After all, the cost of self-built traceability systems is greater. The change from the electronic supervision code to the retrospective code has also made the third-party platform represented by Ali Health more “market-oriented”.

The above-mentioned professionals told Cypress Blue that in order to solve the supply chain efficiency problem, the production company carried out the association of large, medium and small packages at the production and packaging sites, and the source serialization established the association with the large, medium and small packages. You will get the box code and all the smallest packing codes it contains.

In addition, according to the "Guide Opinions of the State Administration of Drug Administration on the Construction of a Drug Information Traceability System" (Guo Yao Jian Yao Guan [2018] No. 35), in the traceability system, each link must be retrospectively verified, and upstream to downstream goods, The downstream must scan the code when receiving the goods. Through the comparison of the code set in the retrospective system and the retrospective verification of one loop at a time, to prevent illegal drugs from entering the legal channels, every link can be checked and the destination can be checked. chase.

"It is equivalent to having a security check at every checkpoint after each drug has an identity card, and each link is interlocked."

Compared with the progress of the self-built traceability system, third-party cooperation platforms have flourished. They are more service-oriented to enterprises and transform products according to their needs. Pharmaceutical companies have become their focus.

Today, the higher-level method for drug traceability has been passed. Now it is a question of the timetable for landing. Over 90% of pharmaceutical manufacturers have assigned codes and established a drug traceability system. The remaining pharmaceutical companies must seize the time.

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